Dendreon Corporation Reports Preliminary Survival Data from Completed Provenge Phase 3 Trial D9901; Final Audited D9901 Data Confirm Preliminary Results.Business Editors/Health/Medical Writers BIOWIRE2K SEATTLE--(BUSINESS WIRE)--Sept. 18, 2003 Dendreon Corporation (Nasdaq:DNDN) today announced preliminary survival data and final audited data from D9901, a completed randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double blind, placebo controlled Phase 3 trial of its Provenge(R) immunotherapy for prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . The results were scheduled to be presented at the Prostate Cancer Foundation (formerly CaP CURE) Tenth Annual Scientific Retreat, taking place in Washington D.C. Sept. 19-21, however the conference was postponed due to hurricane Isabel This article is about the 2003 hurricane; there was also a Tropical Storm Isabel during the 1985 Atlantic hurricane season Hurricane Isabel was the costliest and deadliest hurricane in the 2003 Atlantic hurricane season. . The Provenge D9901 trial was designed to measure time to disease progression and time to development of disease-related pain in men with androgen androgen (ăn`drəjən): see testosterone. androgen Any of a group of hormones that mainly influence the development of the male reproductive system. independent prostate cancer. Patient survival was also measured. Preliminary analysis of survival data from this trial show a median survival of 26.3 months in the patients randomized to the Provenge treated group compared to 19.3 months in patients randomized to the placebo group who never received active therapy; a survival difference of 7 months. Seventy five percent of patients who were randomized to placebo and then had progression of their disease went on to receive active therapy in a crossover salvage protocol that accompanied the D9901 trial. The median survival in the patient population who received salvage Provenge was 23.9 months, a survival difference of 4.6 months compared to placebo. Of the 127 men enrolled in the trial between January 2000 and October 2001, over half (67 men) are still alive, with more than 90 percent having received treatment with Provenge, either as initial treatment or as part of the salvage protocol. Final survival data from D9901 is anticipated to be available in late 2004 to early 2005. "Androgen independent prostate cancer is a highly aggressive disease, with survival time normally in the range of 15 to 19 months and, while this trial was not designed, nor powered, to measure survival, a potential survival benefit of 7 months is substantial and meaningful for asymptomatic a·symp·to·mat·ic adj. Exhibiting or producing no symptoms. Asymptomatic Persons who carry a disease and are usually capable of transmitting the disease but, who do not exhibit symptoms of the disease are said to be , metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. androgen independent prostate cancer patients who have failed all treatment options and have no other form of available therapy," said Mitchell H. Gold, M.D., chief executive officer of Dendreon. "We have previously reported that the results of D9901 indicated that Provenge delays disease progression and the onset of disease-related pain. Together these data provide evidence that Provenge holds promise to change the outlook for the many prostate cancer patients worldwide." "We continue to be encouraged by the promise that Provenge holds for patients with advanced prostate cancer," said John Page, president of US TOO!, the world's largest prostate cancer support group. "Provenge may have the potential to dramatically change the way this disease is treated by offering a targeted therapy that can improve the quality of life for men in dire need of better treatment options." In addition, the company has received the final audited results from the D9901 trial, which confirm the previously reported preliminary results. Comparison of the Provenge treated group to placebo group using the Kaplan-Meier method revealed a clinical benefit, as measured by a delay in time to disease progression, in the Provenge treated group (p = 0.061) that closely approached, but did not achieve, the pre-specified endpoint of the study (p = 0.05). The p value previously reported in the preliminary analysis was (p = 0.085). Final audited results from the trial also confirmed the significant clinical benefit of delay in time to disease progression from Provenge treatment for men with androgen independent prostate cancer with a Gleason score Gleason score Oncology A value derived from the Gleason grading system which is the sum of the 2 most predominant histologic patterns seen in prostate CA of 7 or less (p = 0.001), an improvement from that previously reported in the preliminary analysis (p = 0.002). In addition, for these men, the probability of remaining free of cancer-related pain cancer-related pain, n pain with acute, chronic, and psychological aspects experienced by cancer patients. Associated with the disease process and treatment. while on the study was more than two times higher (p = 0.016), preliminarily reported as (p = 0.019), than for patients treated with placebo. Treatment was generally well tolerated, with mild infusion-related fevers and chills the most common adverse events. Provenge is currently in a pivotal double blind placebo-controlled Phase 3 trial, D9902B, seeking to confirm previous results that indicate the product may delay progression of disease and the development of disease-related pain. Dendreon has received a Fast Track designation for Provenge from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in addition to a positive assessment under the Special Protocol Assessment (SPA) provision indicating that D9902B may serve as the basis for a Biologics License Application for Provenge. To be eligible for the current Provenge D9902B study, patients must have metastatic prostate cancer that has progressed following hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy and have a Gleason score of 7 or less. Patients must also be free of cancer-related pain. Information on Dendreon's clinical trials is available at www.dendreon.com. About Provenge Provenge is designed to stimulate a man's immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase Prostatic acid phosphatase (PAP) is an enzyme produced by the prostate. It may be found in increased amounts in men who have prostate cancer or other diseases. This is also the same enzyme that is found in significant amounts in female ejaculate. (PAP (1) (Password Authentication Protocol) An access control protocol for dialing into a network that provides only basic functionality. When the client logs onto the network, the network access server (NAS) requests the username and password from the client and ). About Prostate Cancer Prostate cancer is the leading cancer diagnosed among men in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . More than one million men in the United States have prostate cancer, with 189,000 cases diagnosed and 30,200 deaths in 2002. There is currently no available therapeutic treatment for asymptomatic metastatic androgen independent prostate cancer. About Gleason Score The Gleason score is the most commonly used prostate cancer scoring system Noun 1. scoring system - a system of classifying according to quality or merit or amount rating system classification system - a system for classifying things and is considered one of the most important prognostic prog·nos·tic adj. 1. Of, relating to, or useful in prognosis. 2. Of or relating to prediction; predictive. n. 1. A sign or symptom indicating the future course of a disease. 2. indicators for prostate cancer. The score is based on tissue findings throughout the prostate that correlate with the aggressiveness of a tumor tumor: see neoplasm. . High Gleason scores are indicative of aggressive cancers and are not associated with a favorable prognosis. In the androgen independent patient population approximately 75 percent of the patients have a Gleason score of 7 or less. Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing , small molecule and prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. product candidates. Dendreon has research and development alliances with Genentech, Inc., Kirin Brewery Co., Ltd., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com. Except for historical information contained herein, this news release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties surrounding the efficacy of Provenge to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include risks related to Dendreon's limited operating history, risks associated with completing our clinical trials, the risk that preliminary analyses of data may not be confirmed by final data, the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license, the risk that the FDA will not be satisfied with the data we provide for Provenge or approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for Provenge or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials for Provenge, dependence on the efforts of third parties, including collaborators, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations, are contained in Dendreon's SEC reports, which are available at www.sec.gov. |
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